Dozuril 25 mg/ml solution for use in drinking water for chickens

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Toltrazuril

Available from:

Dopharma Research B.V.

ATC code:

QP51AJ01

INN (International Name):

Toltrazuril

Dosage:

25 milligram(s)/millilitre

Pharmaceutical form:

Solution for use in drinking water

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Chickens

Therapeutic area:

toltrazuril

Therapeutic indications:

Coccidiostats

Authorization status:

Authorised

Authorization date:

2012-05-25

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Dozuril 25 mg/ml solution for use in drinking water for chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains:
ACTIVE SUBSTANCE:
Toltrazuril
25 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS_ _
Trolamine
Macrogol 300
Clear colourless to yellow-green solution for use in drinking water.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Chickens (pullets and breeders)
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Treatment of coccidiosis in pullets and broiler breeders.
3.3
CONTRAINDICATIONS
None.
3.4
SPECIAL WARNINGS
Good hygiene can reduce the risk of coccidiosis. It is therefore
recommended that any deficiencies in
husbandry should be addressed in addition to treatment. Poultry houses
should be kept clean and dry.
It is recommended that all individuals in the group are treated.
For best results, treatment should be initiated before the clinical
signs of disease have spread
throughout the whole group.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
As with any antiparasitic agent, frequent and repeated use of
antiprotozoal agents from the same class
of active substances and underdosing due to underestimation of the
live weight can lead to the
development of resistance. It is important to keep to the recommended
dose in order to minimise the
risk of resistance.
This veterinary medicinal product should not be used together with
feed additives/or other veterinary
medicinal products that might interfere with the efficacy of the
product, like ‘coccidiostats’ and
‘histomonostats’.
3
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals:
This veterinary medicinal product may be irritating to the skin, eye
or mucous membranes.
Avoid skin and eye contact, including hand-to-eye contact and
hand-to-mouth contact.
Wear personal protective clothing, including synthetic rubber gloves
when handling the